B-K Medical X18L5s User manual

16-01295-EN-05
May 2019 For Professional Users Only
X18L5s (9009) Transducer
User Guide

X18L5s = Ref. Type 9009
LEGAL MANUFACTURER
BK Medical Aps
Mileparken 34
2730 Herlev
Denmark
Tel.:[phone] / Fax:[phone]
www.bkmedical.com
Email: [email protected]
The connector label on a BK Medical transducer contains information about the date of
manufacture.
BK Medical Customer Satisfaction
Input from our customers helps us improve our products and services. Your opinions are important to
us. You are always welcome to contact us via your BK Medical representative or by contacting us
directly.
© 2019 BK Medical
Information in this document may be subject to change without notice.

1
Contents
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Intended use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Caring for the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Reprocessing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Starting Imaging . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Connecting the Transducer. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Changing Frequency. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Using a Transducer Cover . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Using the Transducer Control Button. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Changing Orientation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Operation of X18L5s. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Cleaning after Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
English source version
16-01295-EN-05

2

X18L5s User Guide (16-01295-EN-05) Introduction 3
Introduction
This is the user guide for the X18L5s transducer 1, and it must be used together with
the Care and Cleaning user guide which contains important safety information.
Intended use
The transducer is intended for diagnostic ultrasound imaging or fluid flow analysis
of the human body.
Indications for use
The X18L5s transducer is designed for peripheral vessel (peripheral vascular),
musculoskeletal (conventional/superficial), intraoperative 2, intraoperative
(neuro)
2,3,4 and small organ (small parts) imaging. X18L5s is also suitable for
elastography4.
Patient population
Patient population is infants 5, children, adolescents and adults.
Figure 1. X18L5s transducer
1. X18L5s has not been licensed by Health Canada for use on the bkSpecto.
Physicians
only
Caution Rx-c1
United States Federal law restricts this device to sale by or on the order of a physician.
2. bk5000 only.
3. Use of X18L5s for intraoperative (neuro) has not been licensed by Health Canada.
4. Use of X18L5s for intraoperative (neuro) and elastography has not been CE-marked.
WARNING Cardio-w1
To avoid patient injury, do not use the transducer for applications where it may come in
direct conductive contact with the patient’s heart.
5. Surface use only.

4 May 2019 X18L5s User Guide (16-01295-EN-05)
General Information
Product specifications, acoustic output data and data about EMC (electromagnetic
compatibility) for this transducer can be found in the Product Data Sheet and the
Technical Data (BZ2100) that accompany this user guide.
Service and Repair
Caring for the Transducer
The transducer may be damaged during use or reprocessing, so it must be checked
before use for cracks or irregularities in the surface, following the procedure in Care
and Cleaning. It should also be checked thoroughly once a month following the
same procedure.
Reprocessing
To ensure the best results when using BK Medical equipment, it is important to
maintain a strict cleaning routine.
Complete details and procedures can be found in Care and Cleaning that
accompanies this user guide.
A list of reprocessing methods that the transducer can withstand are listed in the
Product Data Sheet.
Sterile covers are available. See the Product Data Sheet for more information.
WARNING GS-w2
If at any time the system malfunctions, or the image is severely distorted or degraded, or you
suspect in any way that the system is not functioning correctly:
• Remove all transducers from contact with the patient.
• Turn off the system. Unplug the system from the wall and make sure it cannot be used
until it has been checked.
• Do not try to repair the system yourself.
• Contact your BK service representative or hospital technician.
WARNING AO-w1
To avoid tissue damage, always keep the exposure level (the acoustic output level and the
exposure time) as low as possible.
WARNING SR-w1
Service and repair of BK electromedical equipment must be carried out only by the
manufacturer or its authorized representatives. BK Medical reserves the right to disclaim all
responsibility, including but not limited to responsibility for the operating safety, reliability
and performance of equipment serviced or repaired by other parties. After service or repairs
have been carried out, a qualified electrician or hospital technician should verify the safety
of all equipment.

X18L5s User Guide (16-01295-EN-05) Starting Imaging 5
Starting Imaging
Before use, all equipment must be reprocessed according to expected use.
Connecting the Transducer
The transducer is connected to the system using the array transducer socket on the
system. To connect, flip the system’s locking lever to the right. Align the transducer
plug to the system socket and insert securely. Flip the system’s locking lever to the
left to lock it.
When connected, the transducer complies with Type BF requirements of EN60601-1
(IEC 60601-1).
Changing Frequency
The multifrequency imaging (MFI) control enables you to select the imaging
frequency. See the applicable system user guide for instructions.
Using a Transducer Cover
BK recommends the use of a sterile transducer cover to reduce the risk of cross-
contamination. See the Product Data Sheet for a list of available transducer covers.
Follow local guidelines for the use of transducer covers in your area.
NOTE: In the United States of America, it is recommended to use transducer covers
that have been market cleared. In Canada, use only licensed transducer covers. In
Europe, transducer covers must be CE-marked.
WARNING Reproc-w2
Users of this equipment have an obligation and responsibility to provide the highest
possible degree of infection control to patients, co-workers and themselves. The
instructions in this book are meant as a guide. To avoid cross-contamination, follow all
infection control policies (including for reprocessing, packing and storage) for personnel
and equipment that have been established for your office, department or hospital.
WARNING T-w5
To prevent electrical shock and damage to the transducer, the connector pins in the
transducer plug must always be completely dry before you connect to a system.
WARNING GS-w4a
It is essential for the patient’s safety that only the correct equipment is used.
• Do not use other manufacturers’ transducers with BK ultrasound systems.
• Do not use BK transducers with other manufacturers’ systems.
• Do not use unauthorized combinations of transducers and needle guides.

6 May 2019 X18L5s User Guide (16-01295-EN-05)
Apply sterile gel to the tip of the transducer or fill the cover with 1 to 2 ml of sterile
water. This improves screen imaging by preventing image artifacts caused by air
bubbles.
Pull the transducer cover over the transducer. Check for air bubbles between the
cover and the transducer and even out if necessary before proceeding.
For Intraoperative Applications:
• Irrigate the organ to be imaged with 0.9% sterile physiological saline solution
while imaging.
For Surface Use:
• Gel also creates a good acoustic contact between the skin and the transducer:
Therefore, apply a small amount to the outside of the cover prior to imaging and
reapply frequently.
Follow these precautions when putting sterile covers on a transducer:
• Wear sterile gloves.
• When using a puncture attachment, place it gently over the cover and secure it,
following the instructions for the puncture attachment.
• Verify that the cover has not been damaged in the process. If it has, repeat the
procedure with a new transducer cover.
Using the Transducer Control Button
The control button on the transducer controls the imaging.
Press the button to Start or Stop imaging (freeze frame). Press the button for more
than one second to make a copy of the image.
WARNING TC-w7
Use only approved non-pyrogenic, sterile transducer covers. This means that in the USA they
must be market cleared by the FDA and in Europe they must be CE-marked. In Canada, they
must be licensed by Health Canada.
WARNING TC-w1
Some transducer covers can contain latex. Because of reports of severe allergic reactions to
medical devices containing latex (natural rubber), the FDA advises health-care professionals
to identify their latex-sensitive patients and be prepared to treat allergic reactions promptly.
Caution T-c3
Use only water-based gel (sterile if you are using a sterile transducer cover). Products
containing parabens, petroleum, or mineral oils may harm the transducer or transducer
cover.

X18L5s User Guide (16-01295-EN-05) Operation of X18L5s 7
Changing Orientation
To change the orientation of the image on the monitor, refer to the applicable system
user guide for instructions.
Operation of X18L5s
Adjustment of Flexible Tip
The transducer has a flexible tip. The tip can be adjusted through an angle of up to
90in four steps: 0, 30, 60 and 90:
Figure 2. X18L5s’ flexible tip
The transducer should be checked before use for cracks or irregularities in the
surface. It is important to check the black rubber cover on the transducer handle and
the articulation joint on the flexible tip of the transducer to ensure that there are no
defects in these areas. It should also be checked thoroughly once a month following
the procedure in Care and Cleaning.
Intraoperative Imaging with X18L5s
Before intraoperative imaging, refer to Care and Cleaning for disinfection and
sterilization instructions.
Intraoperative (neuro) Imaging with X18L5s
30 ° 60 ° 90 ° 0°
WARNING C-J-w1
Do not use this transducer for neurosurgical applications if the patient is suspected of
having Creutzfeldt-Jakob disease. If a neurosurgical transducer has been used on a patient
suspected of or diagnosed as being Creutzfeldt-Jakob positive, the transducer must be
destroyed, following approved procedures for your hospital.

8 May 2019 X18L5s User Guide (16-01295-EN-05)
NOTE: Ensure that the transducer cable is secured so that it cannot move and pull the
transducer out of position.
Cleaning after Use
Use a suitable brush to make sure that biological material and gel are removed from
all channels and grooves. See Care and Cleaning for cleaning instructions.
Disposal
When the transducer is scrapped at the end of its life, national rules for the relevant
material in each individual land must be followed. Within the EU, when you discard
the transducer, you must send it to appropriate facilities for recovery and recycling.
WARNING TC-w10
Avoid scraping the transducer against any raw bone edges along the drill hole. This could
damage the transducer cover and increase the risk of contamination.
WARNING Exam-w7
To avoid patient injury, do not lean on, bend or apply excessive force when using the
transducer. Remain aware of the location of the tip of the transducer at all times.
WARNING Reproc-w3
Immediately after use, you must pre-clean the device until visually clean (including
device lumens if existing). Conduct the thorough cleaning process as soon as
possible after use in order to prevent bioburden drying on the surface. Dried
bioburden can lead to inefficient cleaning, disinfection and sterilization, causing a
risk of cross-contamination.
WARNING D-w1
For contaminated disposals such as transducer covers or needle guides, follow disposal
control policies established for your office, department, or hospital.